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Outcomes After Esophageal Cancer Surgery (FREGAT I)

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ClinicalTrials.gov Identifier: NCT01927016
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : April 1, 2015
Sponsor:
Collaborators:
French Eso-Gastric Tumors Working Group
Federation of Research in Surgery (FRENCH)
AFC (Association Francophone de Chirurgie)
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

Background

  • Esophageal carcinoma is the sixth leading cause of cancer -related mortality and the eighth most common cancer worldwide
  • The incidence is increasing rapidly
  • The overall 5-year survival ranges from 15% to 25% in the literature and poor outcomes are related to diagnosis at advanced stages.
  • Surgery used to be the cornerstone of treatment of resectable esophageal cancer, but treatment of esophageal carcinoma remains challenging and need to be considered through a multimodal approach. However the modalities and the impact of this multimodal approach at a national level are unknown Primary objective: To identify predictors of recurrence after esophageal cancer surgery

Secondary objectives :

  • 5-year recurrence free survival
  • 5-year overall survival
  • Predictors of postoperative mortality and morbidity after surgery
  • Impact of pCR on recurrence and survival
  • Impact of neoadjuvant treatments on recurrence and survival
  • Impact of patient preconditioning (such as nutritional support, esophageal prosthesis, mini-invasive approach…) on outcomes

Methodology : European French-speaking retrospective multicentric study Inclusion criteria: All consecutive patients operated on, for a histologically proven carcinoma of the esophagus, the oesophago-gastric junction (Siewert type I and II), in surgical investigator centers between January 2000 and December 2010 Exclusion criteria: Siewert III type carcinoma of the oesophago-gastric junction , non surgical treatment of esophageal carcinoma Planned study period: The data will be collected over a 11-year period from January 2000 to December 2010. Follow up will be ascertained in May 2013.


Condition or disease Intervention/treatment
Esophageal Neoplasm Esophageal Disease Procedure: Esophagectomy

Detailed Description:
Patients with an esophageal or junctional carcinoma (including SIewert type I and II) with surgical resection of the primary tumor inclusion date will be date of surgery all patients will be followed during 5 years after surgery or time of death

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Study Type : Observational
Actual Enrollment : 2944 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Factors Linked to Outcomes After Esophageal Cancer Surgery: a Multicenter National Study
Study Start Date : July 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Esophagectomy for cancer
Patients operated on for a cancer of the esophagus, a Siewert I or II cancer of the oesophago-gastric junction
Procedure: Esophagectomy
Esophagectomy for esophageal cancer whatever can be the surgical approach (with or without thoracotomy, minimally invasive or not)




Primary Outcome Measures :
  1. To identify predictors of recurrence after esophageal cancer surgery [ Time Frame: 30 May 2012 ]
    clinical factors linked to 5-year recurrence will be identify through univariable and multivariable analysis


Secondary Outcome Measures :
  1. 5 year recurrence free survival [ Time Frame: 30 May 2012 ]
    events: death and recurrence at 5 years after surgery

  2. 5 year overall survival [ Time Frame: 30 may 2012 ]
    all causes for death at 5 years after surgery

  3. Predictors of postoperative mortality and morbidity after surgery [ Time Frame: 30 May 2012 ]
    30-day postoperative mortality and 30-day overall postoperative morbidity

  4. Impact of pCR on recurrence and survival [ Time Frame: 30 May 2012 ]
    pathological complete response within the tumor and nodes

  5. Impact of neoadjuvant treatments on recurrence and survival [ Time Frame: 30 May 2012 ]
    looking at the impact of neoadjuvant chemo and/or chemoradiation on oncological outcomes

  6. Impact of patient preconditioning (such as nutritional support, esophageal prosthesis, mini-invasive approach…) on outcomes [ Time Frame: 30 May 2012 ]
    looking at the impact of nutritional support, endoscopic and surgical procedures on outcomes



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients operated on for a cancer of the esophagus , a Siewert I or II cancer of the oesophago-gastric junction
Criteria

Inclusion Criteria:

  • All consecutive patients operated on for a cancer of the esophagus , a Siewert I or II cancer of the esopgago-gastric junction in surgical oncology investigator centers
  • Surgery performed between 1st January 2000 and 31 December 2010

Exclusion Criteria:

  • Siewert III cancer of the oesophago-gastric junction
  • Non surgical treatment of the esophageal cancer
  • Benign lesion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927016


Locations
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France
University Hospital, Lille
Lille, France, 59045
Sponsors and Collaborators
University Hospital, Lille
French Eso-Gastric Tumors Working Group
Federation of Research in Surgery (FRENCH)
AFC (Association Francophone de Chirurgie)
Investigators
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Study Director: Christophe Mariette, MD, PhD University Hospital, Lille
Principal Investigator: Caroline Gronnier, MD CHRU Lille
Principal Investigator: Denis Collet, MD, PhD CHU Bordeaux
Principal Investigator: Bernard Meunier, MD, PhD CHU Rennes
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Gronnier C, Tréchot B, Duhamel A, Mabrut JY, Bail JP, Carrere N, Lefevre JH, Brigand C, Vaillant JC, Adham M, Msika S, Demartines N, El Nakadi I, Piessen G, Meunier B, Collet D, Mariette C; FREGAT Working Group-FRENCH-AFC, Luc G, Cabau M, Jougon J, Badic B, Lozach P, Cappeliez S, Lebreton G, Alves A, Flamein R, Pezet D, Pipitone F, Iuga BS, Contival N, Pappalardo E, Mantziari S, Hec F, Vanderbeken M, Tessier W, Briez N, Fredon F, Gainant A, Mathonnet M, Bigourdan JM, Mezoughi S, Ducerf C, Baulieux J, Pasquer A, Baraket O, Poncet G, Vaudoyer D, Enfer J, Villeneuve L, Glehen O, Coste T, Fabre JM, Marchal F, Frisoni R, Ayav A, Brunaud L, Bresler L, Cohen C, Aze O, Venissac N, Pop D, Mouroux J, Donici I, Prudhomme M, Felli E, Lisunfui S, Seman M, Petit GG, Karoui M, Tresallet C, Ménégaux F, Hannoun L, Malgras B, Lantuas D, Pautrat K, Pocard M, Valleur P. Impact of neoadjuvant chemoradiotherapy on postoperative outcomes after esophageal cancer resection: results of a European multicenter study. Ann Surg. 2014 Nov;260(5):764-70; discussion 770-1. doi: 10.1097/SLA.0000000000000955.

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01927016    
Other Study ID Numbers: 2013_01
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by University Hospital, Lille:
Esophageal Neoplasm
Esophagus
Surgery
Outcome assessment
Additional relevant MeSH terms:
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Esophageal Neoplasms
Esophageal Diseases
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Gastrointestinal Diseases